Faculty and Staff

Jurisdiction of the IRB

The IRB is a University standing committee established by Charleston Southern University
to protect the rights and welfare of human and animal research subjects recruited
to participate in research activities conducted under the auspices of the University.
The IRB has the authority to approve, require modifications in, disapprove or suspend
all research activities that fall within its jurisdiction as specified by federal
regulations and policies of the University and affiliated institutions.

The IRB functions independently of, but in coordination with, other university committees.
For example, the Graduate Council may be consulted in research that is conducted for
master's thesis credit. The IRB, however, makes its independent determination whether
to approve or disapprove the protocol based upon whether or not human subjects are
adequately protected.

Charleston Southern University's IRB reserves the right to review all research, even
research that is exempt from review under the federal regulations. The IRB has jurisdiction
over all research, thereby providing broader protection than that required by the
federal regulations. The IRB's authority to approve, require modifications in or disapprove
research derives from both federal law and university policy.

In brief, research is defined as the collection of data for the purpose of broadening
the knowledge base of a discipline. The information gathered is intended to potentially
be available for professional presentation or publication. Research does not include
information gathered only for the assessment of a particular program in which the
information will be only viewed by individuals directly involved with the program.
Research also does not include information gathered only for use within the classroom
situation.

Research that has been reviewed and approved by the IRB may be subject to further
review and disapproval by officials of the institution. Those officials may not, however,
approve research if it has been disapproved by the IRB. Furthermore, approved research
is subject to continuing IRB review and must at a minimum be re-evaluated annually
and more frequently in some cases.

The IRB reviews all research; as such it is not concerned with whether or not a particular
activity is performed with therapeutic intent. This includes, but is not limited to,
development of protocols that guide research that is conducted for therapeutic purposes.
The IRB conducts risk/benefit assessments for research on therapies, for example,
determining if the risks of a study are justified by a therapy provided as part of
the study. Benefit alone is not used to justify risks presented by the research.